Morbid ObesityNCT02113696
Intake of Omega 3 in Morbidly Obese Patients
A study testing Omega 3 intake, morbid obesity in people with Morbid Obesity, run by Pontificia Universidade Católica do Rio Grande do Sul.
Trial summary
Ingestion of capsules of omega 3 EPA and DHA, with 1.8 g of EPA and 1.2 g DHA for morbidly obese patients, will improve the inflammatory status? C-reactive protein? Weight? Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Omega 3 intake, morbid obesity
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women aged between 18-65 years,
- BMI > 40 kg/m2 (or > 35 kg/m2 with comorbidities),
- ambulatory, receiving an oral diet,
- with a diagnosis of metabolic syndrome,
- and who signed a Term of Free and Informed Consent.
Who cannot join
- Systemic inflammatory response syndrome,
- coma or compromised organ,
- fever or infection foci,
- cancer with or without chemotherapy and radiotherapy,
- radiotherapy, inflammatory diseases of the gastrointestinal tract,
- transplant, trauma, surgery or hospital stay in the past 30 days
- use of steroids or non-steroid anti-inflammatory or immunomodulators agents or antibiotics,
- or those refusing to take part in the study.
About this study
Official title: The Effect of ω-3 Polyunsaturated Fatty Acids (Eicosapentaenoic Acid and Docosahexanoic Acid) on Morbidly Obese Patients
Ingestion of capsules of omega 3 EPA and DHA, with 1.8 g of EPA and 1.2 g DHA for morbidly obese patients, will improve the inflammatory status? C-reactive protein? Weight?
Read the detailed description
Intake of EPA and DHA for the management of morbid obesity in capsules
- Reduction of inflammatory factors such as adipokines, glucose, C-reactive protein, cholesterol, weight, BMI. Will be 2 groups: cases and controls. The cases will intake of omega 3 capsules and placebo control.
- Conditions
- Morbid Obesity
- Being tested
- Omega 3 intake, morbid obesity, Placebo Capsules
- Keywords
- morbid obesity, BMI at or above 4O kg/m2, ingestion of omega 3, inflammatory cytokines, biochemical factors, anthropometric factors
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3 intake, morbid obesityDietary supplement
Individuals of both sexes with ages between 18 and 65 years took 3g of omega 3, and 1.8g eicosapentaenoic acid (EPA) and 1.2g docosahexanoic acid (DHA) for 8 weeks.
Placebo CapsulesDietary supplement
They received gelatin (colorless) capsules. A nutritional evaluation was performed, a 24-h recordatory was applied to verify macro and micronutrients intake, biochemical evaluation before and after the intervention. Macro and micronutrients were calculated using the Avanutri 2.0 system. Clinical history was verified through a questionnaire previously filled out by a physician.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Experimental | Placebo Capsules Receives: Dietary Supplement: Placebo Capsules |
| Omega 3 intake | Experimental | Omega 3 intake, morbid obesity Receives: Dietary Supplement: Omega 3 intake, morbid obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of inflammatory levels on blood
expected from this study verify inflammatory factors such as adipokines, glucose, c reactive protein, lipid profile, triglycerides, and anthropometric data as visceral fat, weight, BMI, in both groups, control and intervention, to see the action of the capsules of omega 3.patient may withdraw any time from ingestion of capsules, and the same will be provided by the laboratory Vitamed, which is regularized with the supervisory bodies and food security of Brazil
Measured: 08 weeks
Secondary outcomes (1)
Decrease of weight
The weight will be measured before and after the intake of omega 3.
Measured: 08 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudio C Motin, orientador, Study director, Centro de Obesidade Mórbida da Pontificia Universidade Católica do RS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113696
- Sponsor's protocol ID
- primary
- Status last verified
- Jul 2014
- First submitted
- 27 Mar 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of ω-3 Polyunsaturated Fatty Acids (Eicosapentaenoic Acid and Docosahexanoic Acid) on Morbidly Obese Patients
- ClinicalTrials.gov ID
- NCT02113696
- Acronym / sponsor ID
- primary
- Conditions
- Morbid Obesity
- Keywords
- morbid obesity, BMI at or above 4O kg/m2, ingestion of omega 3, inflammatory cytokines, biochemical factors, anthropometric factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do SulUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ingestion of capsules of omega 3 EPA and DHA, with 1.8 g of EPA and 1.2 g DHA for morbidly obese patients, will improve the inflammatory status? C-reactive protein? Weight?
Detailed description
Intake of EPA and DHA for the management of morbid obesity in capsules
- Reduction of inflammatory factors such as adipokines, glucose, C-reactive protein, cholesterol, weight, BMI. Will be 2 groups: cases and controls. The cases will intake of omega 3 capsules and placebo control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Experimental | Dietary Supplement: Placebo CapsulesPlacebo Capsules |
| Omega 3 intake | Experimental | Dietary Supplement: Omega 3 intake, morbid obesityOmega 3 intake, morbid obesity |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women aged between 18-65 years,
- BMI > 40 kg/m2 (or > 35 kg/m2 with comorbidities),
- ambulatory, receiving an oral diet,
- with a diagnosis of metabolic syndrome,
- and who signed a Term of Free and Informed Consent.
Key exclusion criteria (8 listed)
- Systemic inflammatory response syndrome,
- coma or compromised organ,
- fever or infection foci,
- cancer with or without chemotherapy and radiotherapy,
- radiotherapy, inflammatory diseases of the gastrointestinal tract,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3 intake, morbid obesityIndividuals of both sexes with ages between 18 and 65 years took 3g of omega 3, and 1.8g eicosapentaenoic acid (EPA) and 1.2g docosahexanoic acid (DHA) for 8 weeks. | Dietary supplement | Omega 3 intake |
| Placebo CapsulesThey received gelatin (colorless) capsules. A nutritional evaluation was performed, a 24-h recordatory was applied to verify macro and micronutrients intake, biochemical evaluation before and after the intervention. Macro and micronutrients were calculated using the Avanutri 2.0 system. Clinical history was verified through a questionnaire previously filled out by a physician. | Dietary supplement | Placebo group |
Primary outcome
Decrease of inflammatory levels on blood
Time frame: 08 weeks
expected from this study verify inflammatory factors such as adipokines, glucose, c reactive protein, lipid profile, triglycerides, and anthropometric data as visceral fat, weight, BMI, in both groups, control and intervention, to see the action of the capsules of omega 3.patient may withdraw any time from ingestion of capsules, and the same will be provided by the laboratory Vitamed, which is regularized with the supervisory bodies and food security of Brazil
1 secondary outcome
Decrease of weight
Time frame: 08 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio C Motin, orientador study director
Centro de Obesidade Mórbida da Pontificia Universidade Católica do RS
Questions about this trial
What is this clinical trial studying?
A study testing Omega 3 intake, morbid obesity in people with Morbid Obesity, run by Pontificia Universidade Católica do Rio Grande do Sul.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease of inflammatory levels on blood (time frame: 08 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014; AzTrials last refreshed its copy on 7 Nov 2026.